Good Manufacturing Practices (GMP) are guidelines that ensure the quality and safety of products. GMPs cover the design, production, and monitoring of manufacturing facilities and processes.
Objectives of GMP
Quality: Ensure consistent product quality
Safety: Prevent contamination and manufacturing errors
Traceability: Provide complete product traceability
Compliance: Facilitate regulatory compliance
Risk reduction: Reduce the risk of sanctions and reminders
GMP principles
Quality management
Establish a quality management system to ensure products meet specifications
Documentation
Maintain accurate records to support regulatory compliance, issue tracking, and audits
Materials
Use tested quality materials that are clearly identified and traceable
Personnel training
Ensure personnel have the appropriate qualifications and hygiene
Validation
Demonstrate that instruments, processes, and activities function as expected
Building and facilities
Ensure the facilities and equipment meet sanitary and processing requirements
GMP implementation
GMPs are important for consumer health and safety. Companies are responsible for educating employees about GMPs and ensuring they meet GMP requirements.
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